A Randomized, Double-Blind, Placebo-Controlled Study of Intermittent Doses of CERC-301 in the Treatment of Subjects With Severe Depression Despite Antidepressant Treatment

There is a significant unmet medical need for rapidly acting treatment of subjects with severe major depressive disorder (MDD) who have not adequately responded to antidepressant therapy. Alternative therapies require weeks to achieve full efficacy, may have significant side effects, and still fail in a high percentage of subjects. Rapid reduction of severe depression by pharmacological therapy is important to reduce the need for hospitalization and risk of self-harm and mortality. CERC-301, a highly selective, orally bioavailable, N-methyl-D-aspartate (NMDA) receptor subunit 2B (NR2B), also referred to as Glutamate NMDA receptor subunit epsilon-2 (GluN2B) antagonist, would be a therapeutic breakthrough if it provides rapid onset of antidepressant effects and an effect size similar to that seen with experimental intravenous NMDA modulators.

Start Date01 Jun 2015

Sponsor / Collaborator

Avalo Therapeutics, Inc.

NCT01941043 / CompletedPhase 2

A Randomized, Double-Blind, Placebo-Controlled, Sequential Parallel Study of CERC-301 in the Adjunctive Treatment of Subjects With Severe Depression and Recent Active Suicidal Ideation Despite Antidepressant Treatment

The current study will evaluate the antidepressant effect of CERC-301 during 28 days of treatment in subjects with MDD who are currently experiencing a severe depressive episode despite stable ongoing treatment with selective serotonin- or serotonin-norepinephrine reuptake inhibitors (SSRI or SNRI). The study population will be enriched for subjects that would benefit most from rapid onset, those with recent active suicidal ideation, but not a risk to themselves or others and are deemed appropriate for an out-patient study with careful safety surveillance. This will allow the study to focus on the antidepressant effects of CERC-301 but also explore effects on suicidal ideation. To explore rapid onset, the primary endpoint will be at 7 days, but effects over the 28 days of treatment will be examined as a secondary endpoint.

Start Date01 Nov 2013

Sponsor / Collaborator

Avalo Therapeutics, Inc.

NCT00472576 / CompletedPhase 1IIT

An Investigation of the Antidepressant Effects of the Selective NR2B Antagonist MK-0657 in Major Depression

Purpose : This study will determine whether MK-0657, a selective NR2B Antagonist, can quickly improve symptoms of depressed mood, psychomotor retardation, poor motivation and reduced enjoyment of things in patients with major depression.
MK-0657 decreases the activity of a brain receptor called NMDA, which the chemical glutamate binds to, possibly inducing a rapid antidepressant response. People between 18 and 55 years of age who have major depression of at least 4 weeks' duration and have not been helped by two antidepressants approved for major depression may be eligible for this study. Women who are able to have children are excluded. Participants are admitted to the NIH Clinical Center for two study phases, as follows. Phase I (1 to 2 weeks): Patients are tapered off their current medications. Phase II (7 weeks): Patients are randomly assigned to take either MK-0657 or placebo (look-alike capsules with no active ingredient) by mouth for 12 days. At some point during the second part this phase, patients who had been taking MK-0657 are switched over to placebo and those who had been taking placebo are switched to MK-0657. Participants undergo the following procedures during the study:Physical examination twice (at the beginning and at the end of the study) Electrocardiogram (ECG) four times Blood tests about six times Rating scales up to 28 times to assess the effects of MK-0657 on mood and thinking Blood pressure measurements three times a day.
Study examines the effectiveness of a new medication, targeting a system called glutamate, will improve depression when compared with placebo.

Start Date01 May 2007

Sponsor / Collaborator

National Institute of Mental Health

100 Clinical Results associated with CERC-301

100 Translational Medicine associated with CERC-301

100 Patents (Medical) associated with CERC-301

Literatures (Medical) associated with CERC-301

20 Dec 2023·ACS chemical neuroscience

Characterization of (R)- and (S)-[¹⁸F]OF-NB1 in Rodents as Positron Emission Tomography Probes for Imaging GluN2B Subunit-Containing N-Methyl-d-Aspartate Receptors

Article

Author: Gruber, Stefan ; Gisler, Livio ; Sippl, Wolfgang ; Haider, Ahmed ; Keller, Claudia ; Liang, Steven H ; Wallimann, Rahel ; Ametamey, Simon M ; Ahmed, Hazem ; Elghazawy, Nehal H

The N-methyl-d-aspartate receptor (NMDAR) subtype 2B (GluN1/2B) is implicated in various neuropathologies. Given the lack of a validated radiofluorinated positron emission tomography (PET) probe for the imaging of GluN1/2B receptors, we comprehensively investigated the enantiomers of [¹⁸F]OF-NB1 in rodents. Particularly, the (R)- and (S)- enantiomers were evaluated using in silico docking, in vitro autoradiography, in vivo PET imaging, and ex vivo biodistribution studies. A select panel of GluN1/2B antagonists (CP-101,606, CERC-301, and eliprodil) and the off-target sigma-1 receptor ligands (fluspidine and SA4503) were used to determine the specificity and selectivity of the tested enantiomers. Additionally, a nonmetal-mediated radiofluorination strategy was devised that harnesses the potential of diaryliodoniums in the nucleophilic radiofluorination of nonactivated aromatic compounds. Both enantiomers exhibited known GluN1/2B binding patterns; however, the R-enantiomer showed higher GluN1/2B-specific accumulation in rodent autoradiography and higher brain uptake in PET imaging experiments compared to the S-enantiomer. Molecular simulation studies provided further insights with respect to the difference in binding, whereby a reduced ligand-receptor interaction was observed for the S-enantiomer. Nonetheless, both enantiomers showed dose dependency when two different doses (1 and 5 mg/kg) of the GluN1/2B antagonist, CP-101,606, were used in the PET imaging study. Taken together, (R)-[¹⁸F]OF-NB1 appears to exhibit the characteristics of a suitable PET probe for imaging of GluN2B-containing NMDARs in clinical studies.

01 Oct 2022·European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology

New antidepressants: New day or false dawn?

Article

Author: Young, Allan H ; Jelen, Luke A

A review.This review is on the new antidepressants.Building on evidence for the rapid antidepressant effects of ketamine, investigators have explored whether alternative NMDA receptor antagonists may share ketamine′s antidepressant properties, however clin. studies of several other NMDA receptor antagonists and NMDA receptor site modulators (e.g., memantine, GLYX-13, CERC-301) have failed to produce convincing results.However, despite intranasal esketamine and brexanolone receiving licenses for the treatment of TRD and post-partum depression resp., there are ongoing debates with regards to cost-effectiveness, deliverability, and in ketamine′s case, particular concerns regarding longer-term efficacy, safety, and abuse liability.

12 Sep 2021·Cochrane Database of Systematic Reviews

Ketamine and other glutamate receptor modulators for depression in adults with unipolar major depressive disorder.

Review

Author: Hollingsworth, Sarah ; Marquardt, Tahnee ; Turner, Erick H ; Cipriani, Andrea ; Smith, Rebecca ; McShane, Rupert ; Barnes, Annabelle ; Hawton, Keith ; Hurducas, Claudia ; Dean, Rebecca L ; Spyridi, Styliani ; Cowen, Philip J

BACKGROUND:

Many studies have recently been conducted to assess the antidepressant efficacy of glutamate modification in mood disorders. This is an update of a review first published in 2015 focusing on the use of glutamate receptor modulators in unipolar depression.

OBJECTIVES:

To assess the effects - and review the acceptability and tolerability - of ketamine and other glutamate receptor modulators in alleviating the acute symptoms of depression in people with unipolar major depressive disorder.

SEARCH METHODS:

We searched the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE, Embase and PsycINFO all years to July 2020. We did not apply any restrictions to date, language or publication status.

SELECTION CRITERIA:

Double- or single-blinded randomised controlled trials (RCTs) comparing ketamine, memantine, esketamine or other glutamate receptor modulators with placebo (pill or saline infusion), other active psychotropic drugs, or electroconvulsive therapy (ECT) in adults with unipolar major depression.

DATA COLLECTION AND ANALYSIS:

Three review authors independently identified studies, assessed trial quality and extracted data. The primary outcomes were response rate (50% reduction on a standardised rating scale) and adverse events. We decided a priori to measure the efficacy outcomes at different time points and run sensitivity/subgroup analyses. Risk of bias was assessed using the Cochrane tool, and certainty of the evidence was assessed using GRADE.

MAIN RESULTS:

Thirty-one new studies were identified for inclusion in this updated review. Overall, we included 64 studies (5299 participants) on ketamine (31 trials), esketamine (9), memantine (5), lanicemine (4), D-cycloserine (2), Org26576 (2), riluzole (2), atomoxetine (1), basimglurant (1), citicoline (1), CP-101,606 (1), decoglurant (1), MK-0657 (1), N-acetylcysteine (1), rapastinel (1), and sarcosine (1). Forty-eight studies were placebo-controlled, and 48 were two-arm studies. The majority of trials defined an inclusion criterion for the severity of depressive symptoms at baseline: 29 at least moderate depression; 17 severe depression; and five mild-to-moderate depression. Nineteen studies recruited only patients with treatment-resistant depression, defined as inadequate response to at least two antidepressants. The majority of studies investigating ketamine administered as a single dose, whilst all of the included esketamine studies used a multiple dose regimen (most frequently twice a week for four weeks). Most studies looking at ketamine used intravenous administration, whilst the majority of esketamine trials used intranasal routes. The evidence suggests that ketamine may result in an increase in response and remission compared with placebo at 24 hours odds ratio (OR) 3.94, 95% confidence interval (CI) 1.54 to 10.10; n = 185, studies = 7, very low-certainty evidence). Ketamine may reduce depression rating scale scores over placebo at 24 hours, but the evidence is very uncertain (standardised mean difference (SMD) -0.87, 95% CI -1.26 to -0.48; n = 231, studies = 8, very low-certainty evidence). There was no difference in the number of participants assigned to ketamine or placebo who dropped out for any reason (OR 1.25, 95% CI 0.19 to 8.28; n = 201, studies = 6, very low-certainty evidence). When compared with midazolam, the evidence showed that ketamine increases remission rates at 24 hours (OR 2.21, 95% CI 0.67 to 7.32; n = 122,studies = 2, low-certainty evidence). The evidence is very uncertain about the response efficacy of ketamine at 24 hours in comparison with midazolam, and its ability to reduce depression rating scale scores at the same time point (OR 2.48, 95% CI 1.00 to 6.18; n = 296, studies = 4,very low-certainty evidence). There was no difference in the number of participants who dropped out of studies for any reason between ketamine and placebo (OR 0.33, 95% CI 0.05 to 2.09; n = 72, studies = 1, low-certainty evidence). Esketamine treatment likely results in a large increase in participants achieving remission at 24 hours compared with placebo (OR 2.74, 95% CI 1.71 to 4.40; n = 894, studies = 5, moderate-certainty evidence). Esketamine probably results in decreases in depression rating scale scores at 24 hours compared with placebo (SMD -0.31, 95% CI -0.45 to -0.17; n = 824, studies = 4, moderate-certainty evidence). Our findings show that esketamine increased response rates, although this evidence is uncertain (OR 2.11, 95% CI 1.20 to 3.68; n = 1071, studies = 5, low-certainty evidence). There was no evidence that participants assigned to esketamine treatment dropped out of trials more frequently than those assigned to placebo for any reason (OR 1.58, 95% CI 0.92 to 2.73; n = 773, studies = 4,moderate-certainty evidence). We found very little evidence for the remaining glutamate receptor modulators. We rated the risk of bias as low or unclear for most domains, though lack of detail regarding masking of treatment in the studies reduced our certainty in the effect for all outcomes.

AUTHORS' CONCLUSIONS:

Our findings show that ketamine and esketamine may be more efficacious than placebo at 24 hours. How these findings translate into clinical practice, however, is not entirely clear. The evidence for use of the remaining glutamate receptor modulators is limited as very few trials were included in the meta-analyses for each comparison and the majority of comparisons included only one study. Long term non-inferiority RCTs comparing repeated ketamine and esketamine, and rigorous real-world monitoring are needed to establish comprehensive data on safety and efficacy.

News (Medical) associated with CERC-301

02 Feb 2020

·ir.avalotx.com

Cerecor and Aevi Genomic Medicine Complete Merger

Cerecor Inc. (NASDAQ: CERC), a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare pediatric and orphan diseases, announced today it has completed the previously announced acquisition of Aevi Genomic Medicine (NASDAQ: GNMX) in an all-stock transaction valued at approximately $15.6 million at close, plus contingent value rights (CVRs) for up to an additional $6.5 million in subsequent payments based on clinical and/or regulatory milestones. Cerecor’s pipeline now includes six clinical-stage assets, accelerating the Company’s transformation into a research and development organization focused on developing new medicines for unmet needs in rare diseases, particularly for pediatric patients. The Company continues to explore strategic alternatives for its non-core neurological assets, including CERC-301, as well as its sole commercialized product, Millipred®. Mike Cola, Chief Executive Officer, Cerecor, stated, “Cerecor began this transformation roughly 15 months ago with the acquisition of the CERC-800s, which have the potential to be the first-ever approved treatments for Congenital Disorders of Glycosylation (CDGs). Following the more recent divestiture of the majority of the commercial pediatric portfolio and the acquisition of Aevi, today the Company is proud to advance a robust pipeline of six clinical-stage rare disease programs with the potential to be first-in-class medicines addressing high unmet needs of patients and families. Four of these programs are potentially Priority Review Voucher (PRV) eligible, with three already granted Rare Pediatric Disease Designation (RPDD) by the FDA. Cerecor is focused on achieving several critical inflection points throughout 2020, including initiation of pivotal studies for one or more CERC-800 program(s) and clinical proof-of-concept studies in patients with the recently integrated Aevi assets: CERC-002, CERC-006 and CERC-007. We believe this combination of assets present a unique opportunity to efficiently deliver high impact medicines by leveraging biomarker-driven approaches in clinical development”. For details of the transaction please see the Investor Relations section of Cerecor.com. Michael Cola has been appointed as the Chief Executive Officer and Dr. Garry Neil has been appointed as the Chief Medical Officer of Cerecor. Mr. Cola brings a wealth of leadership experience in the biopharmaceutical industry. Prior to joining Cerecor, Mr. Cola served as President and CEO of Aevi Genomic Medicine since September 2013. Prior to joining Aevi Genomic Medicine, Mr. Cola served as President of Specialty Pharmaceuticals at Shire plc, a global specialty pharmaceutical company, from 2007 until April 2012. He joined Shire in 2005 as EVP of Global Therapeutic Business Units and Portfolio Management. Prior to joining Shire, he was with Safeguard Scientifics, Inc., a growth capital provider to life sciences and technology companies, where he served as President of the Life Sciences Group. While at Safeguard, Mr. Cola served as Chairman and CEO of Clarient, Inc., a cancer diagnostics company subsequently acquired by GE Healthcare, and as Chairman of Laureate Pharma, Inc., Prior to Safeguard Scientifics, Mr. Cola held senior positions in product development and commercialization at Astra Merck, a top 20 U.S. pharmaceutical company, and at Astra Zeneca, a global biopharmaceutical company. Mr. Cola received a B.A. in biology and physics from Ursinus College and an M.S. in biomedical science from Drexel University. He serves on the Board of Directors of Vanda Pharmaceuticals Inc., Sage Therapeutics and Phathom Pharmaceuticals, and currently serves as Chairman of the Board of Governors of the Boys & Girls Clubs of Philadelphia. Prior to becoming the Chief Medical Officer at Cerecor, Dr. Garry Neil served as Chief Scientific Officer of Aevi Genomic Medicine since September 2013. Prior to joining Aevi Genomic Medicine, Dr. Neil held a number of senior positions in the pharmaceutical industry, academia and venture capital. These include Corporate VP of Science & Technology at Johnson & Johnson, and Group President at Johnson & Johnson Pharmaceutical Research and Development, VP of R&D at Merck KGaA/EMD Pharmaceuticals, VP of Clinical Research at Astra Zeneca and Astra Merck. Dr. Neil holds a B.S. from the University of Saskatchewan and an M.D. from the University of Saskatchewan College of Medicine. He completed his postdoctoral clinical training in internal medicine and gastroenterology at the University of Toronto. Dr. Neil also completed a postdoctoral research fellowship at the Research Institute of Scripps Clinic. He is the Founding Chairman of the Pharmaceutical Industry R&D Consortium, TransCelerate Biopharmaceuticals Inc. He also serves on the Boards of Arena Pharmaceuticals, the Reagan Udall Foundation and the Center for Discovery and Innovation at Hackensack Meridian Health. He is past Chairman of the Pharmaceutical Research and Manufacturers Association (PhRMA) Science and Regulatory Executive Committee and the PhRMA Foundation Board. He is a past member of the Boards of GTx Pharmaceuticals, the Foundation for the National Institutes of Health (FNIH), and the Science Management Review Board of the NIH. Additionally, Mr. Cola and Dr. Sol J. Barer will be joining the Board of Directors during the first quarter of 2020. Dr. Barer’s long career as a senior pharmaceutical executive with leadership roles in various biopharmaceutical companies, coupled with his experience and knowledge of the global pharmaceutical industry and extensive scientific expertise will be a valuable addition to the Cerecor Board of Directors. The independent directors of the Board approved, pursuant to NASDAQ Listing Rule 5635(c)(4), the grant of inducement equity awards in the form of stock options to Mr. Cola to purchase 1.2 million shares of common stock, to Dr. Neil to purchase 800,000 shares of common stock and to Dr. Jeffery Wilkins, our new Chief Development Officer, to purchase 375,000 shares of common stock. Each inducement option grant will vest over four years, with the first 25% of such option vesting on the first anniversary of the date of grant, and the remainder vesting in equal monthly installments, subject to the continued service of Mr. Cola, Dr. Neil, or Dr. Wilkins respectively, through the applicable vesting date. Dr. Simon Pedder, Cerecor’s Executive Chairman of the Board, added, “We are extremely pleased to complete this acquisition. We welcome Mike and Garry to Cerecor’s management team and Dr. Barer to our Board of Directors. The combined pipeline and leadership team create an exciting platform for the Company to solidify itself as a leader in rare pediatric and orphan drug development. The team is focused on executing and advancing the pipeline to near-term inflection points throughout 2020 that can set the stage for multiple drug approvals in the years to come, starting as soon as 2021.” CERC-002 (formerly AEVI-002) is an anti-LIGHT (Lymphotoxin-like, exhibits Inducible expression, and competes with HSV Glycoprotein D for HVEM, a receptor expressed by T lymphocytes (part of the Tumor Necrosis Super Family 14)), fully human, monoclonal antibody being developed as a treatment for Pediatric Onset Crohn’s Disease. CERC-002 is currently in a Phase I trial in adult Crohn’s patients and has recently dosed the first patient, we anticipate initial data in the first half of 2020. CERC-006 (formerly AEVI-006) is an mTORC1/2 inhibitor (a class of drugs that inhibit the mammalian target of rapamycin) being developed as a treatment for complex Lymphatic Malformations (LM). LM patients often have activating mutations along the PI3K/AKT/mTOR pathway; sirolimus, an mTORC1 inhibitor, has demonstrated clinical utility in LM. CERC-006 has the potential to improve upon both the safety and efficacy of mTOR inhibition in LM. Cerecor seeks to initiate a Phase 1b/2a proof-of-concept study of CERC-006 in LM patients by the end of 2020. CERC-007 (formerly AEVI-007) is a fully human, anti-IL-18 monoclonal antibody with the potential to address multiple auto-inflammatory diseases, including Adult Onset Stills Disease (AOSD) and Multiple Myeloma (MM). IL-18 is a pro-inflammatory cytokine that stimulates the production of interferon gamma; patients with ASOD and MM show elevated serum levels of IL-18. Cerecor seeks to initiate two separate Phase 1b/2a proof-of-concept studies in ASOD and MM patients in the second half of 2020. CERC-801, CERC-802 and CERC-803 are monosaccharide substrate replacement therapies with known therapeutic utility for the treatment of Congenital Disorders of Glycosylation. Oral administration of these substrates replenishes critical metabolic intermediates that are reduced or absent due to genetic mutation, overcoming single enzyme defects to support glycoprotein synthesis, maintenance and function. The FDA has granted RPDD and Orphan Drug Designation (ODD) to all three CERC-800 programs. CERC-801 and CERC-802 have completed phase 1 studies and the IND filing for CERC-803 is anticipated in the first half of 2020. The Company has an ongoing retrospective study, CDG FIRST, which seeks to collect natural history and treatment-related data for patients diagnosed with PGM1-CDG, MPI-CDG or SLC35C1-CDG who are either treated with or without D-galactose, D-mannose and L-fucose, respectively, as well as patients with other CDGs who are treated with one of the three monosaccharides. Cerecor seeks to initiate a pivotal study for one or more CERC-800 program(s) in 2020, with the first anticipated NDA filing in 2021. Cerecor is a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare pediatric and orphan diseases. The Company is advancing an emerging clinical-stage pipeline of innovative therapies. The Company’s pediatric rare disease pipeline is led by CERC-801, CERC-802 and CERC-803 (“CERC-800 programs”), which are therapies for inborn errors of metabolism, specifically disorders known as Congenital Disorders of Glycosylation (CDGs). The FDA granted Rare Pediatric Disease Designation and Orphan Drug Designation (“ODD”) to all three CERC-800 compounds, thus qualifying the Company to receive a Priority Review Voucher (“PRV”) upon approval of a new drug application (“NDA”). The Company plans to leverage the 505(b)(2) NDA pathway for all three compounds to accelerate development and approval. The Company is also developing CERC-002, CERC-006 and CERC-007. CERC-007 is an anti-IL-18 monoclonal antibody being developed for autoimmune inflammatory diseases such as Adult Onset Stills Disease (AOSD) and Multiple Myeloma, with initial proof-of-concept in patients expected in 2021. CERC-006 is an mTORC1/2 inhibitor targeted towards complex Lymphatic Malformations, also with initial proof-of-concept in patients expected in 2021. CERC-002 is an anti-LIGHT monoclonal antibody currently in a Phase 1 clinical trial; initial proof-of-concept data is expected in the first half of 2020 in Adult Crohn’s Disease, an FDA requirement before proceeding into Pediatric Onset Crohn’s. The Company is also developing one other preclinical pediatric orphan rare disease compound, CERC-913, for the treatment of mitochondrial DNA Depletion Syndrome.

Phase 1Executive ChangeOrphan DrugAcquisition

100 Deals associated with CERC-301

External Link

KEGG	Wiki	ATC	Drug Bank
-	CERC-301	-	DB12063

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Major depressive disorder, moderate (MDD)	Phase 2	US	Avalo Therapeutics, Inc.	01 Jun 2015
Suicidal Ideation	Phase 2	US	Avalo Therapeutics, Inc.	01 Nov 2013
Depressive Disorder, Major	Phase 2	US	Avalo Therapeutics, Inc.	01 Nov 2013
Dyskinesias	Phase 1	-	Merck Sharp & Dohme Corp.	01 May 2007
Parkinson Disease	Phase 1	-	Merck Sharp & Dohme Corp.	01 May 2007
Hypotension, Orthostatic	Phase 1	US	Avalo Therapeutics, Inc.	-
Hyperalgesia	Preclinical	US	Merck & Co., Inc.	24 Jan 2007
Nociceptive Pain	Preclinical	US	Merck & Co., Inc.	24 Jan 2007

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00505843 (0657-006, Pubmed \| Clin Neuropharmacol) Manual	Phase 1	Parkinson Disease	22	MK-0657	irsgbzpwuu(xpgfwoyykx) = fayxsbhmfl rgnxzkthrc (jlpcwcaxds, -5.1 to 0.4) View more	Negative	01 Jan 2017

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